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Study of Treatment Used for Migraine Headaches (MK-0974-076) (MASTER)

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ClinicalTrials.gov Identifier: NCT01421277
Recruitment Status : Terminated
First Posted : August 22, 2011
Results First Posted : September 15, 2014
Last Update Posted : June 20, 2017
Sponsor:
Information provided by (Responsible Party):
Merck Sharp & Dohme Corp.

Study Type Observational
Study Design Observational Model: Cohort;   Time Perspective: Prospective
Condition Migraine
Intervention Drug: Statin Therapy
Enrollment 216
Recruitment Details 216 of the 806 screened participants were eligible for the study and were invited to participate in the online survey.
Pre-assignment Details  
Arm/Group Title Participants Enrolled in Protocol Version (V)1.1 Participants Enrolled in Protocol V2
Hide Arm/Group Description Participants with physician-diagnosed migraine with or without aura who are treatment-naive to triptans, who received their first prescription for a triptan and took at least one dose within 6 months prior to being included in Protocol V1.1 of this study. Participants with physician-diagnosed migraine with or without aura who are treatment-naive to triptans, who received their first prescription for a triptan and took at least one dose within 6 months prior to being included in Protocol V2 of this study.
Period Title: Overall Study
Started 25 191
Completed 25 [1] 99 [1]
Not Completed 0 92
Reason Not Completed
Lack of qualifying event             0             61
Incomplete baseline data             0             31
[1]
Completed the online survey for at least one migraine attack.
Arm/Group Title Participants Enrolled in Protocol Version V1.1 Participants Enrolled in Protocol V2 Total
Hide Arm/Group Description Participants with physician-diagnosed migraine with or without aura who are treatment-naive to triptans, who received their first prescription for a triptan and took at least one dose within 6 months prior to being included in Protocol V1.1 of this study. Participants with physician-diagnosed migraine with or without aura who are treatment-naive to triptans, who received their first prescription for a triptan and took at least one dose within 6 months prior to being included in Protocol V2 of this study. Total of all reporting groups
Overall Number of Baseline Participants 25 191 216
Hide Baseline Analysis Population Description
All eligible particpants. 2 participants did not specify gender in the online questionnaire.
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 25 participants 191 participants 216 participants
41.0  (15.77) 39.8  (13.39) 39.9  (13.65)
Sex/Gender, Customized  
Measure Type: Number
Unit of measure:  Participants
Number Analyzed 25 participants 191 participants 216 participants
Female 20 157 177
Male 5 32 37
Not reported 0 2 2
1.Primary Outcome
Title Number of Participants Using a Triptan for Migraine Attacks
Hide Description Participants reported information online. For this measure, the number of participants who used at least one dose of any newly prescribed triptan for the first time in response to a migraine attack were counted.
Time Frame Up to 3 months
Hide Outcome Measure Data
Hide Analysis Population Description
All screened participants who were fully eligible for the study.
Arm/Group Title Participants Enrolled in Protocol Version V1.1 Participants Enrolled in Protocol V2
Hide Arm/Group Description:
Participants with physician-diagnosed migraine with or without aura who are treatment-naive to triptans, who received their first prescription for a triptan and took at least one dose within 6 months prior to being included in Protocol V1.1 of this study.
Participants with physician-diagnosed migraine with or without aura who are treatment-naive to triptans, who received their first prescription for a triptan and took at least one dose within 6 months prior to being included in Protocol V2 of this study.
Overall Number of Participants Analyzed 25 191
Measure Type: Number
Unit of Measure: Number of participants
25 191
2.Primary Outcome
Title Number of Participants Continuing Triptan Therapy
Hide Description Participants reported information online. For this measure, the number of participants who continued to use a triptan after the first migraine attack were counted; switching from one triptan to another was considered continued use.
Time Frame Up to 3 monoths
Hide Outcome Measure Data
Hide Analysis Population Description
All screened participants who were fully eligible for the study.
Arm/Group Title Participants Enrolled in Protocol Version V1.1 Participants Enrolled in Protocol V2
Hide Arm/Group Description:
Participants with physician-diagnosed migraine with or without aura who are treatment-naive to triptans, who received their first prescription for a triptan and took at least one dose within 6 months prior to being included in Protocol V1.1 of this study.
Participants with physician-diagnosed migraine with or without aura who are treatment-naive to triptans, who received their first prescription for a triptan and took at least one dose within 6 months prior to being included in Protocol V2 of this study.
Overall Number of Participants Analyzed 25 191
Measure Type: Number
Unit of Measure: Number of participants
25 174
3.Primary Outcome
Title Main Reason for Stopping Triptan Use
Hide Description [Not Specified]
Time Frame Up to 3 months
Hide Outcome Measure Data
Hide Analysis Population Description
All screened participants who were fully eligible for the study.
Arm/Group Title Participants Enrolled in Protocol Version V1.1 Participants Enrolled in Protocol V2
Hide Arm/Group Description:
Participants with physician-diagnosed migraine with or without aura who are treatment-naive to triptans, who received their first prescription for a triptan and took at least one dose within 6 months prior to being included in Protocol V1.1 of this study.
Participants with physician-diagnosed migraine with or without aura who are treatment-naive to triptans, who received their first prescription for a triptan and took at least one dose within 6 months prior to being included in Protocol V2 of this study.
Overall Number of Participants Analyzed 25 191
Measure Type: Number
Unit of Measure: Number of partiicpants
Other medications worked better 0 2
Side effects of triptan 0 5
Insurance stopped covering cost 0 2
Physician or health care provider decision 0 1
Triptan did not work 0 7
Time Frame [Not Specified]
Adverse Event Reporting Description Adverse events were not collected for this study.
 
Arm/Group Title Participants Enrolled in Protocol Version V1.1 Participants Enrolled in Protocol V2
Hide Arm/Group Description Participants with physician-diagnosed migraine with or without aura who are treatment-naive to triptans, who received their first prescription for a triptan and took at least one dose within 6 months prior to being included in Protocol V1.1 of this study. Participants with physician-diagnosed migraine with or without aura who are treatment-naive to triptans, who received their first prescription for a triptan and took at least one dose within 6 months prior to being included in Protocol V2 of this study.
All-Cause Mortality
Participants Enrolled in Protocol Version V1.1 Participants Enrolled in Protocol V2
Affected / at Risk (%) Affected / at Risk (%)
Total   --/--   --/-- 
Show Serious Adverse Events Hide Serious Adverse Events
Participants Enrolled in Protocol Version V1.1 Participants Enrolled in Protocol V2
Affected / at Risk (%) Affected / at Risk (%)
Total   0/0   0/0 
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 5%
Participants Enrolled in Protocol Version V1.1 Participants Enrolled in Protocol V2
Affected / at Risk (%) Affected / at Risk (%)
Total   0/0   0/0 
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
There IS an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
The Sponsor must have the opportunity to review all proposed abstracts, manuscripts, or presentations regarding this study 60 days prior to submission for publication/presentation. Any information identified by the Sponsor as confidential must be deleted prior to submission.
Results Point of Contact
Layout table for Results Point of Contact information
Name/Title: Senior Vice President, Global Clinical Development
Organization: Merck Sharp & Dohme Corp
Phone: 1-800-672-6327
EMail: ClinicalTrialsDisclosure@merck.com
Layout table for additonal information
Responsible Party: Merck Sharp & Dohme Corp.
ClinicalTrials.gov Identifier: NCT01421277     History of Changes
Other Study ID Numbers: 0974-076
First Submitted: July 28, 2011
First Posted: August 22, 2011
Results First Submitted: September 8, 2014
Results First Posted: September 15, 2014
Last Update Posted: June 20, 2017